Title: Clinical Project Manager
Full time Monday-Friday, 40 hours per week
of Hire: Temp to Hire
Rate: $65,000 - $85,000 DOE
Our client is seeking a Clinical
Project Manager to support the Emerging Infectious Diseases Branch
(EIDB) located at the Rockledge Office in Bethesda, MD. Our client provides
scientific, technical and programmatic support services to EIDB.
Under the direction of the Associate
Director for Programs and Operations, the Clinical Project Manager (CPM) will
work with a team of Research Physicians to develop project plans and support
budget development activities, track progress of assigned programmatic research
studies under the purview of the Walter Reed Army Institute of Research (WRAIR)
and EIDB. The CPM will organize communication with study teams located in the
U.S. and internationally, and integrate administrative activities supporting
clinical research projects. Travel is required.
- Support EIDB’s multi-site clinical projects by
coordinating operational, administrative, and diverse programmatic
Responsible for management of the day-to-day operations of the research
projects by applying comprehensive knowledge of clinical development and
- Assists with site development including establishing
site logistics. Including, supporting the training and development of all
in-country clinical staff members.
- Work with the project team to develop and maintain
project documentation (project scope, schedule, budgets, communication
plans, & etc.) and monitor progress throughout the duration of the
- Develop and manage study budgets and track any required
project agreements and contracts with EIDB.
- Liaise and work with project area leads to ensure development
of necessary study documentation, clinical database, CRFs, and ICFs.
Liaise with clinical operations team lead to ensure the development of and
adherence to operations documents and procedures. Liaise with regulatory
team lead to ensure compliance with regulatory jurisdiction of each site
and all applicable U.S. agencies.
- Coordinate with team leads in each project area to
prepare written study-related progress reports and oral briefings.
- Assist in the development and management of research
- Assess risks to project performance, and independently
or in collaboration with study team, develop risk mitigation proposals for
consideration by responsible leadership. Implement selected mitigation
plan(s) and monitor outcomes.
- Manage communications within project team, organize
meetings and develop appropriate agendas, managing meeting minutes and the
appropriate dissemination, and follow up on action items with responsible
parties. Support research physicians by assisting with meeting management
and the development of plans, reports and presentations as required.
- Maintains a thorough working knowledge of the company,
MRI, MHRP, EIDB, WRAIR, USAMRMC, and DoD operations, policies and
regulations as they pertain to the work being conducted at EIDB.
- Report and escalate project issues to management as
Required Knowledge, Skills and
Abilities: Ability to work in a fast-paced
research environment, and to plan and manage multiple priorities on different
timelines. Flexibility to handle a variety of tasks and shift priorities as
necessary. This position requires the ability to write progress reports in a
clear and concise manner; excellent organizational, communication and
interpersonal skills; ability to establish goals and agendas. Strong self-management
and organizational skills. Excellent knowledge of clinical trial processes;
thorough knowledge of GCP, human subject research, or equivalent regulations.
Minimum Education: Bachelor’s degree in Life sciences, scientific disciplines
or equivalent required.
Minimum Experience/ Training
Requirements: 6 – 8 years of relevant experience.
6+ years of managing research projects, with strong clinical trials experience.
Work Environment: Set in an office environment.
to obtain and maintain a Tier I investigation/Public Trust and a Common Access
Employment with Level One is
contingent upon successful completion of a background check, which may include,
but is not limited to, contacting your professional references, verification of
previous employment, addresses, education, and credentials, a criminal
background check, drug screening, and a department of motor vehicle (DMV)
One Personnel is an equal opportunity and affirmative action employer. All qualified
applicants will receive consideration for employment without regard to race,
color, religion, sex, national origin, disability, protected veteran status or
other status protected by law.